FDA Issues Import Alert for All Laxachem Organics Products

The FDA is stopping all drugs produced by India-based Laxachem Organics from legally entering the United States after the company refused to allow FDA officials to inspect its facility.

The FDA is stopping all drugs produced by India-based Laxachem Organics from legally entering the United States after the company refused to allow FDA officials to inspect its facility. Now, Laxachem will remain on import alert until it has been fully inspected by the FDA and determined to meet US standards.

Under the Federal Food, Drug and Cosmetic Act, any drugs manufactured at facilities that delay, limit, or deny FDA inspections are deemed adulterated and are prohibited from being distributed. That also applies to active pharmaceutical ingredients (API), which Laxachem creates for repackagers, labelers, and wholesale drug distributors, some of which then sell API to US manufacturers.

One of the products that Laxachem manufactures is docusate sodium USP, according to the company’s website. This drug can relieve occasional constipation and its side effects, including gastrointestinal cramping, bloating, and diarrhea. Other products created by Laxachem are chlorbutol, bronopol, and propyl gallate.

Companies that receive API from Laxachem should not distribute it or products containing API to consumers.